A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-05-21

Brief Summary

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This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).

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Detailed Description

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This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD. Hospitalized patients with comorbid COPD who are at high risk for readmission will be recruited. Specifically patients with comorbid COPD who are to be discharged with (a) admission diagnosis of COPD (GOLD stage II or greater); AND (b) either a prior non-elective hospitalization (one in the past 12 months) OR active smoker. Such participants will undergo questionnaire-based screening for sleep-disordered breathing (STOP-BANG questionnaire) and if they have a high risk for Sleep Disordered Breathing (SDB) (\> 3 points) will undergo an overnight portable sleep study for screening prior to hospital discharge (AHI \> 10 per hour; \>3% oxygen desaturation for hypopneas).

After randomization and prior to discharge, participants will either be initiated on AVAPS-AE therapy (intervention arm) for 60 days or will be referred to the sleep center for further diagnostic testing and therapy initiation (standard of care arm). Participants will complete quality of life questionnaires Functional outcomes of sleep questionnaire (FOSQ) at baseline (in-person), and in 30 and 60 days (by mail) post discharge. Information regarding hospital admission, diagnostic tests, medication changes, and procedures will be collected from all participants. Discharge summaries of re-hospitalizations and office or ER visits, as well as diagnostics tests and therapies received will be collected for measuring healthcare costs.

Participants will have an option to enroll in a registry for a 3 year follow-up and will also be queried on a yearly basis regarding hospitalizations, cardiovascular events, and assessment of vital statistics in the National Death Index registry. The study will conclude when all randomized participants have been followed for a minimum of 60 days.

Conditions

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Breathing-Related Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVAPS-AE Non-invasive ventilation therapy

Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate.

Group Type EXPERIMENTAL

AVAPS-AE Non-invasive ventilation therapy

Intervention Type DEVICE

Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Standard of Care Group

Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AVAPS-AE Non-invasive ventilation therapy

Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Hospitalized patients who are at high risk for readmission who are at least 18 years of age.
2. Specifically patients with (a) admission diagnosis of COPD AND (b) either a prior non-elective hospitalization (One in the past 12 months) OR active smoker who are ready for discharge AND (c) are also found to have sleep-disordered breathing (AHI ≥ 10 per hour; \>3% oxygen desaturation for hypopneas) by overnight portable respiratory study prior to hospital discharge.
3. Bedside spirometry revealing evidence for obstructive lung disease (post-bronchodilator; GOLD stage II or greater (FEV1 \<70% predicted post BD).
4. No previous home Positive Airway Pressure (PAP) or Non- Invasive Ventilation (NIV) use within the past year

Exclusion Criteria

1. Central sleep apnea (Central apnea index \>5 per hour; and/or \>50% are central apneas \& hypopneas)
2. Clinically unstable, i.e., Acute Respiratory Failure, hypotensive shock, uncontrolled cardiac ischemia or arrhythmias, requiring life support ventilation or as otherwise determined by the investigator
3. Participants with Stage III \& IV Chronic Heart Failure as defined by the New York Heart Association (NYHA) Classification
4. Known or expected contraindications for the use of non-invasive ventilation per the assessment of the investigator.
5. Lack of medical insurance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No